Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial

October 28, 2013 updated by: Boehringer Ingelheim

A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial

The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The trial is a prospective, international, multi-centre, randomised (1:1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin.

Approximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with ALS-CPR will be randomised at approximately 40 study centres. Randomisation is done immediately after insertion of an IV line is established. Study drug application, as a single IV bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the ALS-CPR procedure.

PCI facilities will be required at all participating sites, i.e. hospitals receiving patients.

Study Hypothesis:

The primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv).

Comparison(s):

Group A (experimental; fibrinolytic treatment) Tenecteplase, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.

Group B (reference) Placebo, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.

Study Type

Interventional

Enrollment

1050

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Univ.-Klinik f. Anaesthesie Graz
      • Innsbruck, Austria, 6020
        • Univ.-Klinik f. Anaesthesie u. Intensivmedizin
      • Salzburg, Austria, 5020
        • LKH Salzburg, St. Johanns-Spital
      • Wien, Austria, 1090
        • Univ.-Klinik f. Notfallmedizin
  • Belgium
      • Antwerpen, Belgium, 2060
        • Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg
      • Brugge, Belgium, 8000
        • AZ Sint-Jan AV
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Bruxelles, Belgium, 1000
        • CHU Saint-Pierre
      • Bruxelles, Belgium, 1090
        • AZ VUB
      • Kortrijk, Belgium, 8500
        • AZ Groeningen
      • La Louvière, Belgium, 7100
        • CHU de Tivoli
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
      • Liège, Belgium, 4000
        • Chr de La Citadelle
      • Namur, Belgium, 5000
        • CHR de Namur
  • France
      • Besançon cedex, France, 25030
        • Hôpital Jean Minjoz
      • Bobigny cedex, France, 93009
        • Hôpital Avicenne
      • Creteil cedex, France, 94010
        • Hopital Henri Mondor
      • Le Chesnay, France, 78150
        • Hôpital André Mignot
      • Lille cedex, France, 59037
        • Hôpital Régional et Universitaire
      • Melun cedex, France, 77011
        • Hopital Marc Jacquet
      • Montpellier cedex 5, France, 34295
        • Hôpital Lapeyronie
      • Paris cedex 15, France, 75743
        • Hôpital Necker
      • Rouen cedex, France, 76031
        • Hopital Charles Nicolle
      • Toulouse cedex, France, 31059
        • Hopital Purpan
      • Voiron cedex, France, 38506
        • Hôpital Pierre Bazin
  • Germany
      • Berlin, Germany, 14050
        • DRK Kliniken Westend
      • Berlin, Germany, 12200
        • Universitatsklinikum Benjamin Franklin
      • Berlin, Germany, 13504
        • Humboldt-Klinikum
      • Bielefeld, Germany, 33604
        • Städtische Kliniken Bielefeld gem. GmbH
      • Bochum, Germany, 44791
        • Klinikum der Ruhr-Universität Bochum
      • Dortmund, Germany, 44309
        • Knappschaftskrankenhaus Dortmund
      • Freiburg/Breisgau, Germany, 79106
        • Chirurgische Universität Freiburg
      • Göttingen, Germany, 37075
        • Georg-August Universität Göttingen
      • Halle/Saale, Germany, 06120
        • Martin-Luther-Universität Halle
      • Heidelberg, Germany, 69120
        • Universität Heidelberg
      • Jena, Germany, 07740
        • Friedrich-Schiller Universitat Jena
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Kiel, Germany, 24116
        • Berufsfeuerwehr Kiel
      • Mannheim, Germany, 68168
        • Universitätsklinikum Mannheim
      • München, Germany, 81675
        • Klinikum rechts der Isar
      • Saarbrücken, Germany, 66119
        • Klinikum Saarbrücken gGmbH
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm
  • Italy
      • Bergamo, Italy, 24100
        • A. O. Ospedali Riuniti di Bergamo
      • Como, Italy, 22100
        • Ospedale S. Anna
      • Genova, Italy, 16132
        • A. O. Universitaria S. Martino
      • Monza, Italy, 20052
        • A. O. San Gerardo di Monza
      • Pavia, Italy, 27100
        • Policlinico S. Matteo
      • Varese, Italy, 21100
        • Osp. di Circolo Fondazione Macchi
  • Norway
      • Bergen, Norway, N-5021
        • ICU, Haukeland Universitetssykehus
      • Fredrikstad, Norway, N-1603
        • ICU, Sykehuset Østfold Fredrikstad
      • Stavanger, Norway, N-4068
        • Akuttklinikken / NLA, Sentralsjukehuset i Rogaland
      • Tønsberg, Norway, N-3101
        • Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg
  • Spain
      • Almería, Spain, 04009
        • Hospital de Torrecárdenas / ICU
      • Barcelona, Spain, 08036
        • Hospital Clínico Provincial de BCN / Cardiology Service
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofía / ICU
      • Granada, Spain, 18012
        • Vírgen de las Nieves. Critical Care-Emergency Room
      • Jerez de la Frontera, Spain, 11407
        • Hospital de Jerez de la Frontera / ICU
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos / Hemodynamics
      • Malaga, Spain, 29010
        • Hospital Clínico Universitario Vírgen de la Victoria / ICU
      • Sevilla, Spain, 41014
        • Boehringer Ingelheim Investigational Site
      • Vigo, Spain, 36214
        • Complejo Hospitalario Universitario de Vigo / Cardiology
      • Zaragoza, Spain, 50009
        • Hospital Clínico Univ. Lozano Blesa
  • Sweden
      • Gävle, Sweden, 807 87
        • Anestesikliniken
      • Göteborg, Sweden, 413 45
        • Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset
  • Switzerland
      • Lausanne, Switzerland, 1005
        • Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429
      • Lugano, Switzerland, 6900
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients, indicated for pre-hospital ALS-CPR procedures* must fulfil the following inclusion criteria:

  • Age at least 18 years (known or estimated; no upper limit)
  • Out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac arrest(s) after initial ROSC)
  • Witnessed (by eye and/or ear) cardiac arrest
  • BLS-CPR started within 10 min of onset (known or estimated time) and may be performed for up to 10 min, followed by ALS-CPR - or ALS-CPR started within 10 min of onset (known or estimated time)

Subjects who meet any of the following criteria will be excluded from randomisation into the study:

  • In-hospital cardiac arrest
  • Cardiac arrest of presumed non-cardiac origin (e.g., drug overdose, carbon monoxide poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident)
  • Obvious significant internal bleeding
  • Known neurological impairment
  • Known coagulation disorder
  • Known pregnancy
  • Known current participation in any other clinical study
  • Known hypersensitivity to study medication
  • Institutionalised subjects (e.g., prisoner)
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of this study is the 30-day survival rate
Time Frame: 30 days
30 days
The co-primary endpoint of this study is hospital admission
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Return of spontaneous circulation (ROSC)
Time Frame: 30 days
30 days
24-hr survival
Time Frame: 24 hours
24 hours
Neurological and overall outcome at hospital discharge or at day 30, whichever came first
Time Frame: 30 days
30 days
Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first
Time Frame: 30 days
30 days
Major bleeds up to hospital discharge or day 30, whichever came first
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1123.18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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